I never had morning sickness during my pregnancies, but I have seen the misery it causes. Many of my friends have suffered through it with a pale cast to their skin, unable to even sit next to me while I ate, due to the mere smell of food.
In recent years, there hadn’t been anything to help other than ginger ale and saltine crackers. But in April, the FDA approved a drug for morning sickness that had been taken off the market some thirty years ago due to accusations that it caused birth defects. Any association between a medication and birth defects is to be taken seriously, especially after the dark history of Thalidomide.
Thalidomide, a sleeping aid and anti nausea drug taken by pregnant women in the late ‘50s, caused terrible birth defects, and created a new and rigorous set of standards for testing of drugs to be taken by pregnant women.
Now, medications are given a “category” status, and the category rating coincides with the risks the drug could pose to a pregnancy. Category X is the most restrictive, while category A is given to drugs that have failed to show a risk to fetus during controlled human trials.
The “new” morning sickness pill, called Diclegis, has been given the category A status by the FDA. The drug was originally introduced in 1956, under the name Bendectin. But after lawsuits were filed against the drug maker linking the drug with birth defects, the company eventually took the drug off the market, citing that it was too expensive to fight the lawsuits. The FDA maintained that the drug was safe.
In the years that followed the drug maker’s decision to remove Benectin from the market, studies proved that Benectin did not increase the rate of birth defects (the baseline is one birth defect in in 33 births, according to the Center for Disease Control.)
Many experts believe that the medication should never have been taken off the market. Dr. Keith Eddelman, Director of Obstetrics at Mount Sinai said, "It is not a controversial drug, and the data is very convincing. ... This new FDA medication is a great option for pregnant women suffering from morning sickness."
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